Surveillance for Guillain-Barré syndrome after influenza vaccination among U.S. Medicare beneficiaries during the 2017–2018 season. Issue 29 (27th June 2019)

• Record Type: Journal Article
• Authors: Perez-Vilar, Silvia; Wernecke, Michael; Arya, Deepa; Lo, An-Chi; Lufkin, Bradley; Hu, Mao; Chu, Steve; MaCurdy, Thomas E.; Kelman, Jeffrey; Forshee, Richard A.
• Is Part Of: Vaccine. Volume 37:Issue 29(2019)
• Page Start: 3856
• Page End: 3865
• Publication Date: 2019-06-27
• Subjects: Influenza vaccines -- Guillain-Barré syndrome -- Near real-time surveillance -- Sequential tests -- Self-controlled risk interval -- Vaccine safety; aIIV3 adjuvanted influenza vaccine -- AR attributable risk -- CI confidence interval -- CMS Centers for Medicare & Medicaid Services -- CWF Common Working File -- FDA U.S. Food and Drug Administration -- FFS Fee-for-Service -- GBS Guillain-Barré syndrome -- IIV3-HD inactivated trivalent high-dose vaccine -- IIV3+IIV4 inactivated trivalent and quadrivalent standard-dose vaccines -- OR odds ratio -- PPV positive predictive value -- SCRI self-controlled risk interval -- SSD Shared Systems Data -- USPRT updating sequential probability ratio test -- VSD Vaccine Safety Datalink; Vaccines -- Periodicals; 615.372
• DOI: 10.1016/j.vaccine.2019.05.041
• Languages: English
• ISSNs: 0264-410X

Abstract

Highlights: No increased GBS risk following 2017–2018 influenza vaccinations. Increased GBS risk with adjuvanted vaccine, not statistically significant after adjustment. Benefits of influenza vaccines heavily outweigh this potential risk. Abstract: Background: The U.S. Food and Drug Administration and the Centers for Medicare & Medicaid Services have been actively monitoring the risk of Guillain-Barré syndrome (GBS) following influenza vaccination among Fee-for-Service (FFS) Medicare beneficiaries every season since 2008. We present our evaluation of the GBS risk following influenza vaccinations during the 2017–2018 season. Methods: We implemented a multilayered approach to active safety surveillance that included near real-time surveillance early in the season, comparing GBS rates post-vaccination during the 2017–2018 season with rates from five prior seasons using the Updating Sequential Probability Ratio Test (USPRT), and end-of-season self-controlled risk interval (SCRI) analyses. Results: We identified approximately 16 million influenza vaccinations. The near real-time surveillance did not signal for a potential 2.5-fold increased GBS risk either in days 8–21 or 1–42 post-influenza vaccination. In the SCRI analyses, we did not detect statistically significant increased GBS risks among influenza-vaccinated Medicare beneficiaries ≥65 years for either the 8–21 or 1–42-day risk windows for all seasonal vaccines combined, high-dose vaccine, or standard-dose vaccines; we did detect an increased GBS risk in days 8–21 post-vaccination for individuals vaccinated with the adjuvanted vaccine (OR: 3.75; 95% CI: 1.01, 13.96), although this finding was not statistically significant after multiplicity adjustment (p = 0.146). Conclusions: Our multilayered surveillance approach—which allows for early detection of elevated GBS risk and provides reliable end-of-season SCRI estimates of effect size—did not identify an increased GBS risk following 2017–2018 influenza vaccinations. The slightly increased GBS risk with the adjuvanted vaccine, which was not statistically significant following multiplicity adjustment, is consistent with the package inserts of all U.S.-licensed influenza vaccines, which warn of a potential low increased GBS risk. The benefits of influenza vaccines in preventing morbidity and mortality heavily outweigh this potential risk.